Bivona FT19DN50NSA006NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517186833), received between Sep 22, 2019 and Jan 13, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Deformation” (1 report).

1 other recall cover devices cleared under the same FDA submission (K923878); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2020Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TRACHEOSTOMY TUBE WAS REPORTED TO BE TILTED IN THE MIDDLE WITH POSSIBILITY OF WRONG ID SIZE. IT WAS ALSO REPORTED THAT THE OBTURATOR WAS DIFFICULT TO SLIDE IN AND OUT ALONG WITH THE SUCTION CATHETER GETTING STUCK. THE TUBE WAS REMOVED WITH NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9584437 ↗
• InjuryJan 13, 2020Partial Blockage; Partial Blockage

  INFORMATION WAS RECEIVED INDICATING THAT A SMALL PIECE OF PLASTIC WAS NOTED IN THE SHAFT OF A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TRACHEOSTOMY TUBE. IT WAS ALSO REPORTED THAT THE OBTURATOR WAS DIFFICULT TO SLIDE IN AND OUT ALONG WITH THE SUCTION CATHETER GETTING STUCK. THE TUBE WAS REMOVED WITH NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9584434 ↗
• InjurySep 22, 2019Material Deformation; Material Integrity Problem; Material Protrusion/Extrusion; Material Deformation; Material Integrity Problem; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE TIP OF THE SILICONE ON THE TRACHEOSTOMY TUBE SEEMED TO BE UNFINISHED AND ROUGH. THE MOTHER OF THE PATIENT TRIED TO PUT THE TRACHEOSTOMY TUBE IN THE PATIENT BUT IT MADE THE PATIENT COUGH. IT WAS LATER OBSERVED THAT THE DEVICE SEEMED TO HAVE TWO SMALL ROUGH BUMPS ON ONE SIDE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9101906 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K923878. One submission often covers many models, so check the product and lot details in each record.

• Z-0260-2007 · Nov 17, 2006 · Terminated
  Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.